Satellos Presents Interim SAT-3247 Clinical and Biomarker Data in Duchenne Muscular Dystrophy at the 2026 MDA Clinical & Scientific Conference

Executive Summary

• Satellos presented interim efficacy observations from its Phase 2 TRAILHEAD study showing continued hand‑grip strength gains and stable elbow/shoulder strength in adult DMD participants.
• Proteomic analysis of the completed 28‑day CL‑101 Phase 1a/b trial revealed reductions in established DMD biomarkers (AK1, CA3, ENO3, MB, ANKRD2) within two weeks of SAT‑3247 dosing.
• Preclinical mouse studies demonstrated significant muscle‑strength improvements in a model of facioscapulohumeral muscular dystrophy (FSHD), supporting broader therapeutic potential.

Key Details

• TRAILHEAD Phase 2 (adult DMD):
• Hand‑grip strength continued to increase versus CL‑101 baseline.
• Elbow and shoulder strength remained stable through Day 56 after re‑enrollment.

• Participants with higher baseline muscle mass showed greater strength improvements.

• CL‑101 Phase 1a/b (28‑day DMD cohort):

• Serum proteomic profiling of >11,000 proteins identified consistent biomarker reductions after two weeks of SAT‑3247.
• Biomarkers decreased: AK1, CA3, ENO3, MB, ANKRD2.

• Changes observed across all evaluated participants with comparable magnitude.

• Regeneration Index (RI) Tool:

• Novel RI based on established biomarkers was presented; now being applied in the ongoing BASECAMP pediatric study to assess muscle regeneration.

• Preclinical FSHD Mouse Model:

• Twelve‑week dosing of SAT‑3247 produced statistically significant enhancements in muscle strength versus control.

• Findings suggest applicability of SAT‑3247 beyond DMD.

• Conference Presentation:

• Two oral presentations and three poster sessions delivered at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, Orlando, FL.

• Future Plans:

• Continued enrollment in TRAILHEAD and BASECAMP studies.
• Additional clinical outcome assessments ongoing; full data to be posted on Satellos’ Events & Presentations page.

Notable Quotes

“Seeing continued improvements in handgrip strength and the addition of new muscle measurements by dynamometry is both positive and encouraging.” – Frank Gleeson, Co‑founder & CEO, Satellos Bioscience

“Participants with greater baseline muscle mass are demonstrating greater improvements in strength, further supporting our strategy of evaluating SAT‑3247 earlier in disease progression.” – Wildon Farwell, M.D., Chief Medical Officer, Satellos